Evolocumab Side Effects

For the Consumer

Applies to evolocumab: subcutaneous solution

Along with its needed effects, evolocumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking evolocumab:

• Difficulty with breathing or swallowing
• fever
• hives, itching, or rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Some side effects of evolocumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• chills
• cough
• ear congestion
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stuffy or runny nose

• Abdominal or stomach pain
• bladder pain
• bloody or cloudy urine
• blurred vision
• diarrhea
• difficult, burning, or painful urination
• difficulty with moving
• dizziness
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle or joint pain
• muscle stiffness
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• swollen joints

For Healthcare Professionals

Applies to evolocumab: subcutaneous solution

Cardiovascular

Common (1% to 10%): Hypertension^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea (1.8%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (including rash, eczema, erythema, urticaria)^[Ref]

Local

Common (1% to 10%): Injection site reaction (including erythema, pain, bruising)^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, musculoskeletal pain, arthralgia (1.8%)^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Neurocognitive events (0.2%)^[Ref]

Other

Common (1% to 10%): Influenza, fatigue (1.6%)
Uncommon (0.1% to 1%): Contusion^[Ref]

Respiratory

Common (1% to 10%): Influenza, fatigue (1.6%)
Uncommon (0.1% to 1%): Contusion^[Ref]

Immunologic

Rare (less than 0.1%): Development anti-drug antibody^[Ref]

Some side effects of evolocumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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